USPTO Patents Application 10597633

(-

PATENT COOPERATION TREATY

From the

INTERNATIONAL PRELIMINARY EXAMINING AUTHORITY

To:

FENSTER, Paul et al.
FENSTER & COMPANY
INTELLECTUAL PROPERTY LTD.

I . w ,

IL-49002 Petach Tikva
ISRAEL

PCT

NOTIFICATION OF TRANSMITTAL OF
THE INTERNATIONAL PRELIMINARY
REPORT ON PATENTABILITY

(PCT Rule 71.1)

Date of mailing
(dayfrnonth/year)

12.06.2006

Applicant's or agent's file reference
41 4v04493

IMPORTANT NOTIFICATION

International application No.
• PCT/IL2Q05/000442

International filing date (dayAnonth/year)
28.04.2005

Priority date (day/monthfyear)
29.04.2004

Applicant

REABILtTY INC. et a!.

1 , The applicant is hereby notified that this International Preliminary Examining Authority transmits herewith the
international preliminary report on patentability and its annexes, if any, established on the international
application,

2. A copy of the report and its annexes, if any, is being transmitted to the international Bureau for
communication to al! the elected Offices.

3 where required by any of the elected Offices, the International Bureau will prepare an English translation of
the report {but not of any annexes) and wiii transmit such translation to those Offices.

4. REMINDER

The applicant must enter the national phase before each elected Office by performing certain acts (filing
translations and paying national fees) within 30 months from the priority date (or later in some Offices)
(Article 39(1)) (see also the reminder sent by the international Bureau with Form PCT/IB/S01 ).

Where a translation of the international application must be furnished to an elected Office, that translation
must contain a translation of any annexes to the international preliminary report on patentability. It is the
applicant's responsibility to prepare and furnish such translation directly to each elected Office concerned.

For further details on the applicable time limits and requirements of the elected Offices, see Volume II of the
PCT Applicant's Guide.

The applicant's attention is drawn to Article 33(5), which provides that the criteria of novelty, inventive step
and industrial applicability described in Article 33(2) to (4) merely serve the purposes of international
preliminary examination and that "any Contracting State may apply additional or different criteria for the
purposes of deciding whether, in that State, the claimed inventions is patentable or not" (see also Article
27(5)). Such additional criteria may relate, for example, to exemptions from patentability, requirements for
enabling disclosure, clarity and support for the claims.

Name and mailing address of the international
preliminary examining authority:

European Patent Office
D-80298 Munich

Tel +49 89 2399 - 0 Tx: 523656 epmu d
Fax: +49 89 2399 - 4465

Authorized Officer

Ullrich, C

Tel. +49 89 2399-232P

Form PCT/1PEA/416 {January 2004)

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Us SLt. a w sLa £L#

Docketed By_

18

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PENSTER

PATENT COOPERATION TREATY

INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

(Chapter II of the Patent Cooperation Treaty)

(PCT Article 36 and Rule 70)

Applicant's or agent's file reference
414£)4493

international application No.
PCT/IL2 00 5/300442

FOR FURTHER ACTION

See Form PCT/1 PEA/41 6

International filing date (day/monihfyear)
28.04.2005

Priority date (dayAnonth/year)
29.04.2004

International Patent Classification (IPC) or national classification and IPC
INV. A61N1/36 A61B5/11 A61 B5£)488 A61 H1J02

Applicant

REABILITY INC. et al.

1 . This report is the international preliminary examination report, established by this. International Preliminary Examining
Authority under Article 35 and transmitted to the applicant according to Article 36.

2. This REPORT consists of a total of 8 sheets, including this cover sheet.

3. This report is also accompanied by ANNEXES, comprising:

a. M sent to the applicant and to the international Bureau) a total of 4 sheets, as follows:

E3 sheets of the description, claims and/br drawings which have been amended and are the basis of this report
and/or sheets containing rectifications authorized by this Authority (see Rule 70.16 and Section 607 of the
Administrative Instructions).

□ sheets which supersede earlier sheets, but which this Authority considers contain an amendment that goes
beyond the disclosure in the international application as filed, as indicated in item 4 of Box No. I and the
Supplemental Box.

b □ (sent to the Internationa} Bureau onfy) a total of (indicate type and number of electronic carrier(s)) , containing a
sequence listing and/or tables related thereto, in electronic form only, as indicated in the Supplemental Box
Roiatinn tn RftQiiAnr.P I tetina feee Section 802 of the Administrative Instructions).

4. This report contains indications relating to the following items:

Box No.

I

Basis of the report

□

Box No.

II

Priority

Box No.

ill

Non-establishment of opinion with regard to novelty, inventive step and industrial applicability

□

Box No.

IV

Lack of unity of invention

Box No.

V

Reasoned statement under Article 35(2) with regard to novelty, inventive step or industrial
applicability; citations and explanations supporting such statement

la

Box No.

VI

Certain documents cited

Box No.

VI!

Certain defects in the international application

□

Box No.

Vill

Certain observations on tfee international application

Date of submission of the demand
28.02.2006

Date of completion of this report
12.06.2006

Name and maHing address of the international
preliminary examining authority:

— European Patent Office

3& D-80298 Munich
Jf/ Tel. +49 89 2399 - 0 Tx: 523656 epmu d

Authorized officer

Fischer, O I f

Telephone No, +49 89 2399-2327

Form PCT/IPEA/409 (Cover Sheet) (April 2005)

INTERNATIONAL PRELIMINARY REPORT
ON PATENTABILITY

International application No.
PCT/lL2005y000442

Box No, I Basis of the report

1 . With regard to the language, this report is based on

B the international application in the language m which it was filed

□ a translation of the international application into , which is the language
of a translation furnished for the purposes of:

□ international search (under Rules 12.3(a) and 23.1(b))

□ publication of the international application (under Rule 12.4(a))

□ international preliminary examination (under Rules 55.2(a) and/or 55.3(a))

2. With regard to the elements* of the international application, this report is based on (replacement sheets which
have been furnished to the receiving Office in response to an invitation under Article 14 are referred to in this
report as "originally filed" and are not annexed to this report):

Description, Pages

1 -32 as originally filed

Claims, Numbers

1 -31 filed with telefax on 28.02.2006

Drawings, Sheets

1 u-i 77 as originally filed

□ a sequence listing and/or any related tabie(s) - see Supplemental Box Relating to Sequence Listing

3. □ The amendments have resulted in the cancellation of:

□ the description, pages

□ the claims, Nos.

□ the drawings, sheets/figs

□ the sequence listing (specify):

□ any table(s) related to sequence listing (specify):

4. □ This report has been established as if (some of) the amendments annexed to this- report and fisted below
had not been made, since they have been considered to go beyond the disclosure as filed, as indicated in the
Supplemental Box (Rule 70.2(c)).

□ the description, pages

□ the claims, Nos.

□ the drawings, sheets/figs

□ the sequence listing (specify):

□ any table(s) related to sequence listing (specify):

* If item 4 applies, some or all of these sheets may be marked "superseded. "

Form PCT/iPEA/ 409 (April 2005)

INTERNATIONAL PRELIMINARY REPORT International application No.

ON PATENTABILITY PCT/1L2005/000442

Box No. Ill Mon-establishment of opinion with regard to novelty, inventive step and industrial
applicability

i . The questions whether the claimed invention appears to be novel, to involve an inventive step {to be non-
obvious), or to be industrially applicable have not been examined in respect of:

□ the entire international application,
M claims Nos. 31

because:

E3 the said international application, or the said claims Nos, 3.1 relate to the following subject matter which
does not require an international preliminary examination (specify):

see separate sheet

□ the description, claims or drawings (indicate particular elements below) or said claims Nos. are so unclear
that, no meaningful opinion could be formed (specify);

□ the claims, or said claims Nos. are so inadequately supported by the description that no meaningful opinion
could be formed (specify).

M no international search report has been established for the said claims Nos. 31

□ a meaningful opinion could not be formed without the sequence listing; the applicant did not, within the
prescribed time limit:

□ furnish a sequence listing on paper complying with the standard provided for in Annex C of the
Administrative Instructions, and such listing was not available to the International Preliminary
Examining Authority in a form and manner acceptable to it.

□ furnish a seauence iistinq in electronic form complying with the standard provided for in Annex C
of the Administrative SnstTuctions, and such listing was not available to the Internationa! Preliminary
Examining Authority in a form and manner acceptable to it.

□ pay the required late furnishing fee for the furnishing of a sequence listing in response to an
invitation under Rules 13ter.1(a) or (b) and 13fer.2.

□ a meaningful opinion could not be formed without the tables related to the sequence listings; the applicant
did not, within the prescribed time limit, furnish such tables in electronic form complying with the technical
requirements provided for in Annex G-bis of the Administrative Instructions, and such tables were not
available to the International Preliminary Examining Authority in a form and manner acceptable to it.

□ the tables related to the nucleotide and/or amino acid sequence listing, if in electronic form only, do not
comply with the technical requirements provided for in Annex C-bis of the Administrative Instructions.

□ See separate sheet for further details

Form PCT/IPEA/ 409 (April .2005)

INTERNATIONAL PRELIMINARY REPORT international application No.

ON PATENTABILITY PCT/1L200 5^)00442

Box No, V Reasoned statement under Article 35(2) with regard to novelty, inventive step or industrial
applicability; citations and explanations supporting such statement

1. Statement

Novelty (N) Yes: Claims

No: Claims 1-7,11-13,15-18,20,26,27,29

Inventive step (IS) Yes: Claims

No: Claims 8-10,14,19,21-25,28,30

Industrial applicability (I A) Yes: Claims 1-30

No: Claims

2. Citations and explanations (Rule 70.7):
see separate sheet

Box No. VI Certain documents cited

1. Certain published documents (Rule 70.10)
and /or

2. Non-written disclosures (Rule 70.9)
see separate sheet

Box No. VII Certain defects in the international application

The following defects in the form or contents of the international application have been noted:
see separate sheet

Form PCT/1PEA/409 {April 2005)

INTERNATIONAL PRELIMINARY
REPORT ON PATENTABILITY
(SEPARATE SHEET)

International application No.
PCT/IL2005/000442

Re item liL

No search has ben carried out (Rule 39.1 (iv) PCT) for claim 31 , since it relates to a method
for treatment of the human or animal body by therapy. Indeed, claim 31 pertains to the
delivery of a therapeutic neuromuscular stimulation signal to the human body. Consequently,
no opinion will be formulated with respect to the subject-matter of this claim (Article 34(4)(a)(i)
PCT).

Re Item V,

1 . Reference is made to the following documents:

D1 : WO 02/092164 A (FONDATiON SUISSE POUR LES CYBERTHESES;
. BRODARD, ROLAND; CLAVEL, REYMON) 21 November 2002
D2 : US 5 466 21 3 A (HOGAN ET AL) 1 4 November 1 995
D3 : US 4 499 900 A (PETROFSKY ET AL) 1 9 February 1 985
D4 : US 4 724 842 A (CHARTERS ET AL) 1 6 February 1 988

2. The present application does not meet the criteria of Article 33(1) PCT, because the
subject-matter of claim 1 is not new in the sense of Article 33(2) RCT.

2.1 Preliminary remark

it is pointed out that the features of the "mechanical motion element coupled to at least
one of said body portion and a mirror body portion " and the IJ EMG sensor coupled
to said mirror body portion " only indicates the suitability of the respective parts of the
apparatus to be coupled to the body: in fact, they rather define the use of the apparatus
rather than clearly defining the apparatus in terms of its technical features. The features
emphasised in bold do therefore not limit the scope of claim 1 (Article 6 PCT).

2.2 Document D1 (see in particular figs, 1-4) discloses (the references in parentheses
applying to this document) an apparatus for muscle activation comprising;

- at least one electrode (37, 38) adapted to deliver a neuromuscular stimulation signal
to a body portion;

Form PCT/Separate Sheet/409 (Sheet 1) (EPO-Aprii 2005}

INTERNATIONAL PRELIMINARY
REPORT ON PATENTABILITY
(SEPARATE SHEET)

international application No.
PCT/IL2005/000442

- at least one controller (31) adapted to provide a NMES signal comprising a sequence
of stimulation signals to said at ieast one electrode; and

- a mechanical motion element (2, 3, 4, 6, 7, 8, 20, 21, 22) suitable (adapted) to be
coupled to at least one of said body portion and a mirror body portion,

- wherein said mechanical motion element is operatively coupled to said at least one
controller (see fig. 4) and wherein said at least one controller controls said NMES signal
in conjunction with said mechanical motion element (p. 12, 2nd paragraph and p. 21,
second and third paragraphs).

Further, as becomes apparent from p. 19, I. 13-15 and L 30-32, a feedback control
based on the muscular activity controller is implemented in the controller of D1 : indeed,
D1 discloses the use of muscular model established by analysing the EMG signal of a
mirror body portion (see p. 19, L 30-32). Hence, at least one EMG sensor is disclosed
by D1 and the EMG sensor is certainly adapted to be coupled to a mirror body
portion.

D1 clearly discloses the "double feedback" as claimed in claim 1 (i.e. mechanical motion
feedback and EMG feedback) (see p. 21, I. 15-28: Closed-Loop Electrical Muscle
Stimulation).

Accordingly, all the features of claim 1 are anticipated by D1 and claim 1 therefore lacks
novelty (Article 33 (2) PCT).

2.3 Further, D2 (see in particular col. 3, L 3-7; col, 6, L 54-59; fig. 14) also anticipates the
subject-matter of claim 1, since it discloses an apparatus for muscle activation
comprising:

- at least one electrode (E1 or E2) adapted to deliver a neuromuscular stimulation signal
to a body portion;

- at least one controller (AB, 32) adapted to provide a NMES signal comprising a
sequence of stimulation signals to said at least one electrode; and

- a mechanical motion element (10) suitable to be coupled to at ieast one of said body
portion and a mirror body portion,

- wherein said mechanical motion element is operatively coupled to said at least one
controller and wherein said at least one controller controls said NMES signal in
conjunction with said mechanical motion element (col, 6, I. 54-59).

Form PCT/Separate Sheet/409 (Sheet 2) (EPO-Aprii 2005)

INTERNATIONAL PRELIMINARY
REPORT ON PATENTABILITY
(SEPARATE SHEET)

International application No.
PCT/IL2005/000442

D2 (col. 3, I. 3-7) discloses also an EMG sensor used in combination with an NMES
stimulator ("'Electromyographic implementation: feature and a Functional Electric
Stimulation implementation feature).

3. Dependent claims 2-30 do not contain any features which, in combination with the
features of any claim to which they refer, meet the requirements of the PCT in respect
of novelty and/or inventive step, the reasons being as follows;

3.1 D1 anticipates the subject-matter of following claims (Article 33 (2) PCT):

- Claims 1 -5: in D1 , the mechanical motion element moves, guides and measures motion
of the body portion (first leg) and the mirror body portion (second leg), which motion is
in response to said NMES sequence.

- Claim 6: the controller of D1 is programmable, so a programmer is implicitly disclosed
inD1.

- Claim 7: in D1 , a closed loop feedback control for booth the mechanical motion and the
EMG controlled stimulation is effected: hence a sequence optimisation is also disclosed.

- Claims 11-13: see D1 , p. 21, second and third paragraphs.

- Claim 1 5: see memory (39) of D1 .

- Claims 1 6-18: in D1 , the operator can modify the stimulation sequence as desired (see
p. 19, 4th paragraph - p. 20, 3rd paragraph).

- Claim 20: force sensor (35) in D1 .

- Claim 26: in D1, one can choose from stimulation only, stimulation assisted
rehabilitation and "mechanical" rehabilitation only (see p. 21, last paragraph - p. 23, 3rd
paragraph): therefore, the controller can act independently of the mechanical motion
element.

- Claim 27: in D1 , the electrodes are placed on the thighs and on the tegs (see fig. 4),
hence the NMES sequence is for application to at least two muscles.

- Claim 29: mechanical motion elements (2, 3, 4) and motors (20, 21 1 22) of D1
represent a robotic actuator (see also p, 15, I. 2).

3.2 The features of claims 8-10, 14, 19, 21-25, 28 and 30 represent slight constructional
changes from the known devices (see documents D1-D4) which come within the scope
of the customary practice followed by persons skilled in the art, especially as the

Form PCT/Separate Sheet/409 (Sheet 3) (EPO-April 2005)

INTERNATIONAL PRELIMINARY
REPORT ON PATENTABILITY
(SEPARATE SHEET)

International application No.
PCT/IL2005/000442

advantages thus achieved can readily be foreseen. Moreover, these features concern
straightforward possibiiities from which the skiiied person wouid select, in accordance
with circumstances, without the exercise of inventive skill, in order to improve the known
devices. Consequently, the subject-matter of these claims lacks an inventive step (Article
33 (3) PCT.

Re Item VI.

Certain published documents

Application No
Patent No

WO 2004/050172

Publication date
( day/month/year)

17.06.2004

Filing ciate
( day/month/year)

03,12.2003

Priority date (valid claim)
(day/month/year)

04.12,2003

This document could become relevant for novelty in further proceedings before the EPCX

Re Item VII.

1- Contrary to the requirements of Rule 5.1(a)(ii) PCT, the relevant background art
disclosed in the documents D1 and D2 is not mentioned in the description, nor are these
documents identified therein.

Form PCT/Separate Sheet/409 (Sheet 4) {EPO-Aprif 2005)

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Wiiiiliii;} . PmISmI

414/04493 A01

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CLAIMS

1 • Apparatus for muscle activation, comprising:

at least one electrode CilXS *a*t«*a tr, „ _

„ / ^ wuva a neuromuscular stimulation

(NMES) signal to a body portion (146);

at le ast one controller (1 24) adapted to provide a NMES signal comprising a
sequence of stimulation signals to said at least one electrode (1 38);

a Mechanical motion element (300) coupled to at least one of said body
portion (146) and a minor body portion (102), wherein said mechanical motion
element (300) is operatively coupled to said at least one controller (124) and wherein
W at least one controller (124) control, said NMES signal in conjunction with said
mechanical motion element (300); and,

at least one EMG sensor (104) coupled to said mirror body portion (102)
herein said controller (124) is adapted to generate said NMES signal based on
sensed EMG signals fiom said at least one EMG sensor (1 04).

2. Apparatus according to claim 1, wherein said mechanical motion element
(300) moves said body portion (146).

3- Apparatus according to claim 1 or claim 2, wherein said mechanical motion
element (300) measures motion of said body portion (146), which motion f s in
response.to said NMES sequence.

4. Apparatus according to any of the preceding claims, wherein said mechanical
. mouon element (300) guides motion of said body portion (146), which motion is in
response to said NMES sequence.

5- Apparatus according to any of the preceding claims, wherein said mechanical
motion element (300) guides motion of said mirror body portion (102), which NMES
is generated in response to said motion.

6- Apparatus according to any of the preceding chums, comprising a programmer
adapted to program NMES sequences for said electrodes (138).

33

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7. Apparatus according to claim 6, wherein said programmer includes a sequence
optimizer which modifies NMES sequences in response to at least one optimization
criterion.

0X0

S- Apparatus according to claim 7, wherein said optimization criterion comprises
the ability of a patient.

9- Apparatus according to claim 7, wherein said optimization criterion comprises
electrode limitations.

1 0. Apparatus according to claim 7, wherein said optimization criterion comprises
a quality of result, as measured by said mechanical motion element (300).

11. Apparatus according to claim 1, further comprising at least one EMG sensor
coupi ed to a mixror body portion (102) on a different person for measuring EMG
signals from the different person.

12. Apparatus according to claim 1, further comprising at least one EMG sensor
(148) coupled to said body portion (142) for measuring EMG signals from the body
portion (142).

13. Apparatus according to claim 12, wherein said controller (124) generates a
NMES signal responsive to at least one of an amplitude arid existence of EMG signal
at a location to which NMES is to be applied.

!

14. Apparatus accotding to any of the preceding claims, wherein said controller
(124) is adapted to generate an indication of which electrodes of said at least one
electrode to use.

15. Apparatus according to any of the preceding claims, comprising a memory
storing therein a plurality of NMES sequences, for at least one daily activity.

* i

1 6. Apparatus according to any of the preceding claims, comprising a user input
for generating a NMES sequence.

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17. Apparatus according to any of the preceding claims, wherein said controller
(124) is adapted to generate a NMES sequence for use for said electrodes based on a
desired motion of said body portion (146\

1 8. Apparatus according to any of the preceding claims, wherein said controller
(124) is adapted to modify a stored NMES sequence for use for said electrodes based
on a desired motion of said body portion (146).

19. Apparatus according to any of the preceding claims, wherein said controller
(1 24gs;:adapted to compare an actual effect of a NMES sequence and a desired effect

J r^dr* said sequence and detect at least one deviation.

20. Apparatus according to any of the preceding claims, wherein said mechanical
motion element (300) is adapted to measure force applied by said body portion (146)
in response to said NMES .

2 1 . Apparatus according to any of the preceding claims, comprising a calibrator
adapted to calibrate at least one sensor associated with motion of said portion.

22. Apparatus according to any of the preceding claims, comprising an interactive
user guide for electrode NMES programming.

23. .. ^Apparatus according to any of the preceding claims, wherein said electrodes
are implantable.

24. Apparatus according to any of the preceding claims, wherein said electrodes
form part of a prosthesis.

25. Apparatus according to any of the preceding claims, wherein said electrodes
are adapted to be worn for the long term.

)

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26. Apparatus according to any of the preceding claims, wherein said electrodes
and at least one of said at least one controller (124) are adapted to act independently
of and removed from said mechanical motion element (300),

27. Apparatus according to any of the preceding claims, wherein said NMES
sequence comprises a sequence for application to at least two muscles.

28. Apparatus according to any
sequence is at least 20 seconds long,

NME!

29. Apparatus according to any of claims wherein said mechanical motion element
(300) comprises an actuator.

30. Apparatus according to claim 29, wherein said actuator comprises a robotic
actuator with at least 3 degrees of motion.

31- A method of electrode setting for NMES ? comprising:
applying a NMES sequence to a limb (146);
measuring motion of the limb (146);

modifying said NMES sequence responsive to said measured motion; and
repeating said applying, said measuring and said modifying, using a
mechanical motion element (300) to at least one of move said limb (146),. resist
motion of said limb (146) and measure motion of said limb (146).

36

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